Charu Taneja

Axillary dissection in the context of the biology of lymph node metastases.

BACKGROUND Modern breast surgery, as the primary treatment of invasive breast carcinoma, has been evolving over the last century. Aggressive radical surgery, which included chest wall resection, complete axillary clearance and internal mammary node dissection, has slowly changed to a less aggressive approach. This has been based on an improved understanding of the biology of the disease. Over the years, randomized prospective trials, performed at centers all over the world, have demonstrated that axillary dissection does not impact on the overall survival while it helps with loco-regional control of breast cancer. Its major role, at the present time, is limited to staging and prognostication; functions that are equally well served by the limited approach of a sentinel node biopsy. SOURCES This review is based on the available medical literature involving the biology and organ specificity of the metastatic process, not only in breast cancer but also in other malignancies. In addition, studies pertaining to clinical breast cancer, and the role of surgery in its treatment, were reviewed. The ongoing trials on the role of sentinel node biopsy in the management of the clinically node negative patients are discussed. CONCLUSIONS This review covers the history, pathophysiology, and clinical basis of the current role of axillary dissection for invasive breast cancer. From the data presented we hope that the medical community will agree that there is no therapeutic role for extended axillary dissection at the current time.

Can Dialysis Patients Be Accurately Identified Using Healthcare Claims Data

♦ Background: While health insurance claims data are often used to estimate the costs of renal replacement therapy in patients with end-stage renal disease (ESRD), the accuracy of methods used to identify patients receiving dialysis — especially peritoneal dialysis (PD) and hemodialysis (HD) — in these data is unknown. ♦ Methods: The study population consisted of all persons aged 18 - 63 years in a large US integrated health plan with ESRD and dialysis-related billing codes (i.e., diagnosis, procedures) on healthcare encounters between January 1, 2005, and December 31, 2008. Using billing codes for all healthcare encounters within 30 days of each patient’s first dialysis-related claim (“index encounter”), we attempted to designate each study subject as either a “PD patient” or “HD patient.” Using alternative windows of ± 30 days, ± 90 days, and ± 180 days around the index encounter, we reviewed patients’ medical records to determine the dialysis modality actually received. We calculated the positive predictive value (PPV) for each dialysis-related billing code, using information in patients’ medical records as the “gold standard.” ♦ Results: We identified a total of 233 patients with evidence of ESRD and receipt of dialysis in healthcare claims data. Based on examination of billing codes, 43 and 173 study subjects were designated PD patients and HD patients, respectively (14 patients had evidence of PD and HD, and modality could not be ascertained for 31 patients). The PPV of codes used to identify PD patients was low based on a ± 30-day medical record review window (34.9%), and increased with use of ± 90-day and ± 180-day windows (both 67.4%). The PPV for codes used to identify HD patients was uniformly high — 86.7% based on ± 30-day review, 90.8% based on ± 90-day review, and 93.1% based on ± 180-day review. ♦ Conclusions: While HD patients could be accurately identified using billing codes in healthcare claims data, case identification was much more problematic for patients receiving PD.

Clinical and Economic Burden of Peristomal Skin Complications in Patients With Recent Ostomies

PURPOSE: The purpose of this study was to estimate the risk and economic burden of peristomal skin complications (PSCs) in a large integrated healthcare system in the Midwestern United States. DESIGN: Retrospective cohort study. SUBJECTS AND SETTING: The sample comprised 128 patients; 40% (n = 51) underwent colostomy, 50% (n = 64) underwent ileostomy, and 10% (n = 13) underwent urostomy. Their average age was 60.6 ± 15.6 years at the time of ostomy surgery. METHODS: Using administrative data, we retrospectively identified all patients who underwent colostomy, ileostomy, or urostomy between January 1, 2008, and November 30, 2012. Trained medical abstractors then reviewed the clinical records of these persons to identify those with evidence of PSC within 90 days of ostomy surgery. We then examined levels of healthcare utilization and costs over a 120-day period, beginning with date of surgery, for patients with and without PSC, respectively. Our analyses were principally descriptive in nature. RESULTS: The study cohort comprised 128 patients who underwent ostomy surgery (colostomy, n = 51 [40%]; ileostomy, n = 64 [50%]; urostomy, n = 13 [10%]). Approximately one-third (36.7%) had evidence of a PSC in the 90-day period following surgery (urinary diversion, 7.7%; colostomy, 35.3%; ileostomy, 43.8%). The average time from surgery to PSC was 23.7 ± 20.5 days (mean ± SD). Patients with PSC had index admissions that averaged 21.5 days versus 13.9 days for those without these complications. Corresponding rates of hospital readmission within the 120-day period following surgery were 47% versus 33%, respectively. Total healthcare costs over 120 days were almost

Role of sentinel lymph node biopsy (SLNB) and preoperative MRI in the management of patients with pure high-grade ductal carcinoma in situ (DCIS).

80,000 higher for patients with PSCs. CONCLUSIONS: Approximately one-third of ostomy patients over a 5-year study period had evidence of PSCs within 90 days of surgery. Costs of care were substantially higher for patients with these complications.

Risk of skeletal-related events (SREs) in patients with breast cancer (BC) and newly diagnosed metastases to bone.

87 Background: The overall incidence of SLN metastases in pure DCIS is < 1% and the results of SLNB do not usually impact treatment or survival but adds significant surgical morbidity. In addition, there is no evidence regarding the role of preoperative MRI in the management of DCIS. The purpose of our study was to identify the efficacy of SLNB and the benefit of preoperative MRI in high-grade DCIS. METHODS We performed retrospective review of 364 patients with DCIS, identified through our cancer registry database, that were seen from 2003 to 2012 at our institution. Of these, 62 patients were diagnosed with high-grade DCIS (Grade 3 or 2 with comedonecrosis) by core needle biopsy, and underwent SLNB. The remaining 302 patients had either low-grade DCIS or did not have a SLNB. RESULTS Median age was 56 years (range 33-80). Sixty two patients had high-grade DCIS on definitive excision and 2/62 patients were noted to have small invasive focus of disease. 15/62 (24.19%) patients underwent mastectomy and 47/62(78.1%) underwent lumpectomy. No patient had a positive SLN (0/62). 15/62 (24.2%) patients had breast MRI preoperatively and among them, in 5 (33.3%) patients, MRI findings changed the surgical decision to mastectomy. Among these 5 mastectomy patients, four of them (80%) had pathologically confirmed findings consistent with preoperative MRI suspicions. In lumpectomy patients, close margin of less than 1mm was seen in 4/9 (44.4%) patients with staging MRI and in 24/38 (63.15%) patients without MRI (p = 0.45. Fishers exact test). However the positive margin leading to re-excision was seen in 2/9 (22.2%) patients who underwent lumpectomy with staging MRI, and 9/38 (23.6%) patients who underwent lumpectomy without staging MRI. CONCLUSIONS In our study, no patient with high grade DCIS had a positive sentinel node suggesting that routine sentinel node biopsy is not necessary in DCIS patients. The use of MRI changed the surgical planning in 33.3% of patients, but did not improve the surgeons ability to achieve clear margins.

Hepatic artery infusion for recurrent or chemotherapy-resistant hepatic malignancy.

91 Background: Bone is a common site of metastatic involvement in patients (pts) with BC. Bony metastases (mets) are often associated with SREs (spinal cord compression [SCC], pathologic fracture [PF], surgery to bone [SB], radiotherapy to bone [RT]). Skeletal complications cause significant morbidity and mortality. Current estimates of SRE risk come principally from randomized clinical trials. Information from routine clinical practice is limited. METHODS Using the tumor registry and electronic data stores at a large U.S. Midwest healthcare system that serves approximately 800,000 persons, we retrospectively identified all pts aged ≥18 yrs with primary BC and newly diagnosed bone mets between 1/1/95 and 12/31/09. Electronic medical records were reviewed by trained abstractors for evidence of SREs between date of bone mets diagnosis and death, loss to follow-up, or end of study. Cumulative incidence of SREs was estimated in the presence of competing risk of death. RESULTS We identified a total of 378 pts with primary BC and newly diagnosed bone mets; 87 pts had evidence of SREs at initial diagnosis of bone mets and were excluded from the analyses. Among the remaining 291 pts, mean (SD) age was 58.2 yrs (14.3 yrs), and 99% were women; 48% were African-American and 46% were Caucasian. Median duration of follow-up after diagnosis of bone mets was 16.1 months (mos). At 12 mos, cumulative incidence of SREs was 44.5% (SCC, 5.2%; PF, 21.0%; SCC and/or PF, 23.3%; SB, 7.6%; RT, 34.3%) (Table). Corresponding figures at 24 mos were 53.8% (SCC, 7.5%; PF, 29.3%; SCC and/or PF, 32.5%; SB, 9.4%; RT, 41.7%). Approximately one-half (45.0%) of study subjects received intravenous bisphosphonates prior to SRE. CONCLUSIONS Pts with BC in routine clinical practice are at high risk of SREs following initial diagnosis of bone mets. [Table: see text].

Changing patterns of failure of head and neck cancer.

e14151 Background: Previously treated hepatic colorectal metastases (CRC) and advanced hepato cellular cancer (HCC) are tumor challenges frequently unresponsive to systemic chemo therapy (CT). We reviewed survival outcome in chemo-resistant/high-risk patients following hepatic artery infusion (HAI) in 21 CRC pts, 10 HCC pts, and 6 miscellaneous metastatic cancers. METHODS Patient groups: 21 CRC pts (16M, 5 F), mean age 63, 16 had metachronous (DFI-17 mos), and 5 synchronous CA; liver extent: 76% multiple (>5) mets or extensive bilateral, CEA (ng/m), >100, 8 pts > 50 (3 pts) < 5 (3 pts) and , NA - 7 pts. Previous CT: FU/LV (11pts), oxaliplatin (OX) or irinotecan (IR) (10 pts). Liver surgery: partial resection/RFA - 9 pts. HCC: (9 PTS), cholangio CA(1), M/F 5/5; av. age 63. Previous RX hepatic lobectomy 4 pts, RFA/TACE - 3 patients. Miscellaneous GP (therapy): Hepatic lobectomy + HAI were done in metastatic lung (1), Breast (1), advanced gall bladder cancer (GBCA; T 3-4; 2 pts); HAI alone was done in Br. CA (1) carcinoid (1) treatment protocols: CRC protocol: HAI-FUDR 12-15mg/kg/d, dexamethasone 2mg.kg/d, leukovorin 20mg/m2 /d (14 d) plus bolus infusion (d1), oxaliplatin (OX) 130mg/m2 (or cisplatin [CIS] 100mg/m2 d1); systemic RX: d20-30. OX I.V. 130mg/m2, capecitabine 750-1,000mg/m2/d x 10 days (also used in Miscel. Grp.) HCC Protocol: HAI-14 d as in CRC protocol. Bolus infusion d1-doxorubicin 75mg/m2 or OX or CIS as in CRC schema. RESULTS CRC: OS-CRC post start HAI = med/16mos., 2yr/5yr = 27%/6%. HCC OS = 9 mos. Median (3-12 mos in 9 evaluable pts.; 1 HCC pt, with recurrence 2 yr. post central hepatectomy was treated over 3.5 yrs. with HAI + RFA/TACE - (OS-67 mo).Miscellaneous group included lung (11 mos) Br CA (23, 9 mos) adv. carcinoid (3 mos), GBCA (2 pts > 60 mos), major complications; pump malfunction (4 pts), misperfusion (2) pts, infected pocket (2) pt, duodenal fistula (1) pt. CONCLUSIONS Hepatic artery infusion alternating with systemic chemo therapy has apparent survival benefit in selected patients with persistent or progressive chemo resistant malignancy from metastatic CRC, HCC, or selected miscellaneous cancers (breast, lung, liver, gall bladder cancer) and warrants further study.